Trials / Completed
CompletedNCT00108953
A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).
Detailed description
In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations. The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints. The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin | Multi kinase inhibitor plus Chemotherapy |
| DRUG | Doxorubicin/Placebo | Chemotherapy plus Placebo |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2005-04-22
- Last updated
- 2014-10-31
- Results posted
- 2009-06-11
Locations
28 sites across 6 countries: United States, Argentina, Canada, Hong Kong, Russia, United Kingdom
Source: ClinicalTrials.gov record NCT00108953. Inclusion in this directory is not an endorsement.